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FDA ANDA · ANDA206969

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Sponsor: GLENMARK PHARMS LTD

APPLICATION
ANDA206969
TYPE
ANDA
ORIGINAL APPROVAL
2016-01-20
LATEST ACTION
2024-05-31
ROUTE
ORAL, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL-21

Approval history

2024-05-31Labeling · Supplement 5 · standardAP
2024-05-31Labeling · Supplement 1 · standardAP
2024-05-31Labeling · Supplement 6 · standardAP
2016-01-20UNKNOWN · Original · standardAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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